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Modified Application of Cardiac Rehabilitation for Older Adults (MACRO)

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ClinicalTrials.gov Identifier: NCT03922529
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Washington University School of Medicine
Information provided by (Responsible Party):
Daniel Forman, MD, University of Pittsburgh

Brief Summary:
Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical gap in cardiovascular disease (CVD) management by melding cardiac rehabilitation (CR) principles with geriatric risk modifying strategies in an intentional and flexible treatment approach. MACRO is designed to optimize accessibility and effectiveness, and to augment the potential for recovery from CVD events that are highly prevalent and otherwise prognostically dire. MACRO constitutes an important advance in geriatric cardiology wherein the conventional approach to CVD care is transmuted and enriched by linking cardiovascular management to the broader complexity of aging.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiac Rehabilitation Transition of Care Behavioral: MACRO Other: Standard of Care Not Applicable

Detailed Description:

This is a pragmatic randomized controlled trial (RCT) of 480 older adults eligible for cardiac rehabilitation (CR): hospitalized adults aged ≥70 years with a primary diagnosis of acute myocardial infarction (AMI)/ Acute coronary syndrome (ACS), stable Ischemic Heart Disease (IHD),Coronary artery bypass graft surgery (CABG), Percutaneous Coronary Intervention (PCI), valvular heart disease (valve replacements or repairs for aortic stenosis or mitral regurgitation), or heart failure (HF). Participants who consent to participate will be randomly assigned to Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) or standard of care (SOC) arms (which may include CR at the discretion of the providers). In the MACRO arm, participants will benefit from personalized engagement, de-prescribing, and CR will be explicitly facilitated, risk stratification will be utilized to determine the best option of CR care from flexible range of options (site-, home, or hybrid). While SOC may include CR, the SOC CR provides no specialized engagement, and no programmatic facilitation, enhancement, customization, or deliberate flexibility in how care is provided. It will be entirely standard care.

Aim 1: To establish efficacy, safety and acceptability of the MACRO intervention.

Investigators hypothesize that after 3 months, compared to standard of care (SOC), participants randomized into the MACRO arm will have:

H1.1: Greater improvements in the Short Physical Performance Battery (SPPB) (primary outcome); H1.2: Greater improvements in physical activity (accelerometry), depression; cognition; frailty; self-efficacy; and quality of life; H1.3: Greater CR participation and adherence; H1.4: Greater impact in readmissions and hospitalization.

Aim 2: To examine duration of benefit from the MACRO compared to SOC H2.1: the investigators hypothesize that relative MACRO benefits (in outcomes, safety, and utilization) will persist after 6 and 12 months

Aim 3: To explore characteristics of participants who benefit the most from the MACRO intervention.

H3.1: the investigators anticipate functional capacity and other baseline characteristics will identify those who benefit from the MACRO intervention (exploratory).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be two intervention groups 1) Standard of Care (SoC) arm which will receive care as determined by their clinical providers. 2) Modified application of cardiac rehabilitation for older adults (MACRO) arm in which the research team will work with the participant and providers to increase facilitation of care in addition to providing enhanced medical rehab goal setting.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Key investigators and well as the outcomes assessor at each site will remain blinded to participant group placement.
Primary Purpose: Supportive Care
Official Title: Modified Application of Cardiac Rehabilitation for Older Adults
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of Care
Care after an acute heart event will be at the discretion of the participants clinical providers.
Other: Standard of Care
Participants will follow the standard of care hospital practice that is recommended for the participant. The study will follow the participant for the course of the study to see the comparison to the MACRO arm

Experimental: MACRO
Research staff will provided personalized engagement, de-prescribing, and explicitly facilitate enrollment into Cardiac Rehabilitation with risk assessment placement to determined the best fit of a flexible range of options of cardiac rehab (site-, home, or hybrid).
Behavioral: MACRO
Modified application of cardiac rehabilitation for older adults (MACRO) intervention transforms Cardiac Rehabilitation by organizing relative to participants' goals of care and composite risks rather than central emphasis on cardiovascular disease (CVD). Participants are engaged, assessed for their goals of care as well as their risks, and education is initiated to best facilitate informed choices regarding realistic and practical strategies. Selection of site-, home-, or hybrid-based care is based on which option will best meet that individual participant's preferences and comprehensive needs. preferences and needs, and utilizing a flexible range of options (site-, home, or hybrid).




Primary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: After 3 months ]
    The Short Physical Performance Battery (SPPB) assesses balance, gait speed, and 5 chair raise. Creating a composite score form 0-12 with 12 being a higher score 0 being the lowest score.


Secondary Outcome Measures :
  1. Accelerometry [ Time Frame: After 3 months ]
    Change in life style physical activity will be measured by wrist worn accelerometry to assess change in movement. We will look specifically at change in step count, vector magnitude, and change in intensity level. Higher the number the better.

  2. PATIENT HEALTH QUESTIONNAIRE (PHQ-9). [ Time Frame: After 3 months ]
    PHQ 9 is a 9 item depression scale. Scores range form 0-27 with the higher score showing the greater possibility of depression.

  3. National institutes of health toolbox cognition battery (NIH toolbox) [ Time Frame: After 3 months ]
    Is an online (will be completed on an IPAD) set of question that allow assessment of change in cognition. This assessment is optional and may not be completed on all participants .

  4. Fried frailty Assessment [ Time Frame: After 3 months ]
    FRIED assessment is a questionnaire the looks at frailty through both physical measures and questions looking at change in body habitus and cognition. Frail: ≥3 criteria present; Intermediate or Pre-Frail:1 or 2 criteria present; Robust : 0 criteria present

  5. Sullivan Cardiac Self-Efficacy [ Time Frame: After 3 months ]
    the self-efficacy scale evaluates an individuals confidence to take care of them self in association to their cardiac disease. Scored on zero to 52 for a total score with the higher the score showing the more confident a person is.

  6. THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) [ Time Frame: After 3 months ]
    RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.

  7. Cardiac Rehabilitation participation and adherence [ Time Frame: After 3 months ]
    Participants will be asked about participation and adherence in cardiac rehabilitation as well as participants medical records to evaluate utilization of cardiac rehab. The greater number of sessions attended the better usually ranging from zero to 36

  8. Readmission/Hospitalization [ Time Frame: After 3 months ]
    Participants will be asked about as well as participants medical records to evaluate readmission to the hospital. Based on the total number of events the lower the number the better

  9. Short Physical Performance Battery (SPPB) [ Time Frame: After 6 and 12 months ]
    The Short Physical Performance Battery (SPPB) assesses balance, gait speed, and 5 chair raise creating a composite score form 0-12 with 12 being a higher score.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥70 year
  • Eligible cardiovascular disease (CVD) diagnosis (hospitalization for Acute myocardial infarction (AMI)/ Acute coronary syndrome (ACS), stable Ischemic Heart Disease , revascularization Coronary artery bypass graft surgery and Percutaneous Coronary Intervention[CABG, PCI], valvular heart disease [specifically, surgical or percutaneous intervention for mitral regurgitation or aortic stenosis], or heart failure (HF))
  • English speaking
  • able to provide written informed consent
  • able to be assessed and undergo study interventions.

Exclusion Criteria:

  • Unstable medical condition as indicated by history, physical exam, and/or laboratory findings
  • Presence of non-CVD conditions likely to be fatal within 12 months (e.g., metastatic cancer)
  • Severe cognitive impairment: Short Blessed screening with a score of 13 or greater or cannot consent (as indicated by medical record)
  • Long-term care resident at admission with no plans to return to independent living
  • anticipates inability to return for required reassessments at 3, 6 and 12 months
  • long-term care residents at admission with no plans to return to independent living.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922529


Contacts
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Contact: Daniel E Forman 412-864-2507 formand@pitt.edu
Contact: Kelly Allsup 412-360-2489 kelly.allsup@va.gov

Locations
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United States, Missouri
Washington University in St. Louis Not yet recruiting
Saint Louis, Missouri, United States, 63130
Contact: Eric Lenze, MD    314-362-5154      
Contact: Angela Stevens    314-362-5154      
Principal Investigator: Eric Lenze, MD         
United States, Pennsylvania
VA Pittsburgh Healthcare system Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Daniel Forman    412-360-2411    daneil.forman@va.gov   
Contact: Kelly Allsup    412-360-2489    kelly.allsup@va.gov   
Principal Investigator: Daniel Forman, MD         
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Washington University School of Medicine
Investigators
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Principal Investigator: Daniel E Forman University of Pittsburgh

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Responsible Party: Daniel Forman, MD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03922529     History of Changes
Other Study ID Numbers: PRO18040009
1R01AG060499-01 ( U.S. NIH Grant/Contract )
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiovascular Diseases